Keystone Manufacturing, LLC

Keystone Solutions Group is a medical device contract manufacturing and outsourcing partner based in Kalamazoo, Michigan. The company specializes in providing complete manufacturing solutions for medical device companies, including assembly, kitting, packaging, converting, sterilization management, and distribution. Keystone operates multiple cleanroom environments and offers services spanning the entire product lifecycle—from prototype and pilot builds to full-scale commercial production. Core capabilities include custom product transfer management, supply chain sourcing, warehousing, and logistics support. The company has developed a proprietary Customer Product Transfer Process that guides clients through project planning, design transfer, process validation, and commercial release. Keystone serves medical device manufacturers seeking cost-effective outsourcing alternatives, particularly startups and early-stage companies. The facility includes substantial square footage dedicated to manufacturing operations and has launched numerous customer programs. While regulatory certifications are not explicitly detailed on the website, the emphasis on cleanroom operations and sterilization management suggests alignment with FDA and ISO 13485 requirements for medical device manufacturing. Keystone functions as a contract manufacturer and service provider rather than an original equipment manufacturer.